Amgen Response to Recent New York Times Stories and an Editorial That Are Based on Misunderstanding of the Facts

THOUSAND OAKS, Calif., (Updated on January 29, 2013)

Amgen is disappointed by recent reporting by the New York Times. Through its misunderstanding of important key facts, the Times has done a disservice to dialysis patients, who are among our nation’s most chronically ill, representing disproportionately high numbers of minority and elderly patients. In its original story “Fiscal Footnote: Big Senate Gift To Drug Maker,” a more recent editorial, and then another story “What the Small Player Can Expect When Using a Lobbyist”, the paper has taken an important Medicare provision in recent legislation out of context. The Times further erred by concluding that the provision was a “gift” to our company without understanding the complexities associated with Medicare dialysis care and the potential harm to patients if the provision had not been included.

In response to the Times’ reporting, we want to make clear a few key facts:

The Times reported that the provision would extend an Amgen patent, but the law does nothing to address patents. Nothing in the legislation makes any change to the patent life of any Amgen product.

All that the provision does is temporarily extend the current way that Medicare Part D covers certain medications while other major changes are being made to the way Medicare pays for dialysis care. Far from creating any special “gift” or directing any money to Amgen, the provision simply continues to allow Medicare patients to receive these needed medications from their pharmacies just like Medicare patients do with most of their prescriptions. Patients will receive these therapies when their physicians determine they are needed and prescribe them, just as they do today.

Our medication represents about a third of the spending for the products addressed by this provision. Our medicine, along with other medications for dialysis patients affected by this law, would continue to be paid for under Medicare Part D like the vast majority of all prescriptions. There are no special patents, special prices, or special incentives, just Medicare Part D coverage, plain and simple.

The same legislation (which we supported) contained other changes to the way that Medicare pays for dialysis, and those other changes could lead to over $5 billion less in payments for dialysis care. It is important not to separate those other changes requiring Medicare to reduce spending for dialysis care by billions of dollars from the provision focused on by the NY Times in its coverage. It was in light of the substantial modifications being made to reduce dialysis care payments that Congress determined that making another change at the same time was too much of a risk for this critical patient population.

The Times said that the provision was added at the last minute, but it was put in at the same time as other health provisions, which prevented a significant cut to Medicare payments to physicians. Moreover, this issue is not new, and Amgen is not alone in being concerned about rushing to change how these medicines are provided. In fact, this issue has been debated since 2009. Other research-based companies have also educated Congress on this issue and rural dialysis providers have long warned the government of the operational complexities associated with delivering these medicines outside of the traditional Medicare Part D pharmacy-based system.

In recognition of these challenges, Congress tasked the independent Government Accountability Office (GAO) to examine the ability of the Medicare program to ensure access to these vital dialysis medicines if the way they are provided is changed. The GAO found in 2011 that Medicare program did not have the right data and quality monitoring systems in place to protect patients and providers. They found that particularly providers in rural areas would have challenges in providing these necessary therapies.

Given that the Medicare program had not enacted measures to address many of the issues raised in the GAO report and in light of the other significant changes being made to dialysis care in the same legislation, Congress may be commended for acting.

The misunderstanding of key facts by the Times is detrimental to furthering the care of some of our nation’s most vulnerable patients. We hope that these facts will help provide a fuller understanding of why Congress chose to act to protect patient access.